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BMI Study for Children Ages 6-9 Years and Parents

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitwits office tool and games
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages 6-9 regardless of BMI status

Exclusion Criteria:

  • non-English-speaking

Sites / Locations

  • UPMC St.Margaret Bloomfield/Garfield Family Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fitwits Intervention

Arm Description

Fitwits office tool and games

Outcomes

Primary Outcome Measures

Improved parent correct identification of child BMI category (surveys)
improved correctness of BMI category selection on surveys over one year

Secondary Outcome Measures

Full Information

First Posted
March 26, 2015
Last Updated
July 16, 2018
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02421822
Brief Title
BMI Study for Children Ages 6-9 Years and Parents
Official Title
BMI Study for Children Ages 6-9 Years and Parents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 14, 2015 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test the Fitwits office tool and games with 6-9 year old children and their parents to: 1) assist parent-child dyad with correct BMI status identification and understanding; 2) address nutrition, portion size, and activity cues; and, 3) track BMI trajectory over 12-month period.
Detailed Description
The investigators will study parents' perceptions of their child's BMI before and after the Fitwits intervention with a primary goal of improving parents' ability to identify their child's actual BMI status (underweight, healthy weight, overweight, or obese). Secondary goals are to measure changes in behaviors and BMI trajectories with repetitive use of the Fitwits office tool. The study design is a longitudinal non-randomized intervention study with four time points (baseline, 3, 6, and 12 months). The investigators will recruit family medicine residents, fellows, and faculty at the investigators' three family health centers and enroll 150 parent/guardians and children aged 6-9 years at well child visits, regardless of initial BMI. The investigators will use electronic health record-generated BMI percentages, the physician-led Fitwits Office Tool as the intervention, and self-reported surveys for the parent-child dyad. Surveys will record the BMI understanding -pre- and post-Fitwits intervention at each visit. The investigators will compare the intervention to a control group residency-based family health center with usual care for child/parent dyads presenting at well child care and 12 months later. At this site the investigators will survey for correct parent identification of the child's BMI category.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
487 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fitwits Intervention
Arm Type
Experimental
Arm Description
Fitwits office tool and games
Intervention Type
Other
Intervention Name(s)
Fitwits office tool and games
Intervention Description
Physician-led narration of Fitwits office tool during well child and subsequent visits over one year with distribution of Fitwits games during first visit.
Primary Outcome Measure Information:
Title
Improved parent correct identification of child BMI category (surveys)
Description
improved correctness of BMI category selection on surveys over one year
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 6-9 regardless of BMI status Exclusion Criteria: non-English-speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann L McGaffey, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC St.Margaret Bloomfield/Garfield Family Health Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States

12. IPD Sharing Statement

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BMI Study for Children Ages 6-9 Years and Parents

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